STATIN SAGA: Medical ethics question 'miracle' of statins to cut cholesterol

Cardiovascular diseases kill like nothing else. WHO pegs its victims at almost 18 million globally. In India, cardiovascular diseases cause one-fourth of all deaths.

All these alarming figures also mean that statins are possibly among the most popular drugs prescribed globally to reduce cholesterol, the main reason for heart attacks. By 2020, sale of these group of drugs is expected to touch $1 trillion.

Under attack

However, lately, statins' popularity has come under attack due to their mighty side-effects – muscle and liver damage, memory loss and diabetes, to name a few. The Lancet (a weekly peer-reviewed medical journal) lists a study carried out in 2015 which states that new types of statins "would not reduce the adverse side-effects of increased risk of Type 2 diabetes".

It is unusual for medical journals to have public spats, but debates on the drug have been raging for the past years in the public domain. Lancet's position is that current evidence does not warrant withdrawal or restrictions on statins. The British Medical Journal argues that such evidence is suspect as it is based on data not made available in the public domain.

Public Trials

Dr Amar Jesani, editor of the Indian Journal of Medical Ethics, said the bigger problem is that the data on clinical trials are not fully in the public domain. "Before a company introduces a medicine, it conducts trials to ascertain its hypothesis about the efficacy. Why is the data of these trials not made public?" he asks.

Dr Prashant Gupta, a Delhi-based pulmonologist, said that many drug trials are carried out by pharma companies. "Should one then not expect biased results?," he asks, "Even so, let them at least be made public. Let us know who the trials were conducted on, what guidelines were used."

Who conducts trials

Dr Jesani, who has also served as a resource person in several short courses in research bioethics, adds that "ghost management" of publication of research data in medical journals has increased over the years. Papers are often written by paid anonymous writers, under the supervision of the pharma companies. The companies then find respectable academics to lend their names as authors for publication.

A recent Cochrane (a British charity that organizes medical research findings to facilitate evidence-based choices about health) review showed that sponsorship of drug trials by the manufacturing company leads to more favourable results and conclusions than sponsorship from other sources. In the case of statins, a vast majority of trials are sponsored by the industry.

DNA wrote to Sun Pharma to ask the pharma company its point of view. While the Corporate Communications representative did ask for questions, no answers came forth even after two weeks and a reminder.

DNA also inquired with USV Pharma, found no response there either.

Normal cholesterol, yet?

Those with 'normal' cholesterol also suffer heart attacks. "What is the answer to that?," asks Dr Gupta, "If cholesterol is not the only reason why people suffer from heart attacks, then why stress so much on lowering cholesterol?"

Years ago, blood sugar reports in India spoke about cholesterol. That graduated to LDL ('bad' cholesterol that leads to cholestrol build-up) and HDL (High Density Lipoproteins, or 'good' cholesterol that carries cholesterol from other parts of your body back to your liver). Now, one also checks for triglycerides (a type of fat (lipid) found in blood). Earlier, cholesterol had to be under 250 to be considered normal. Then 200, then 150. Now it needs to be between 70-100.

Who needs to take statins

Guidelines on who should be prescribed statins are not easily to be found in India, at least not in the public domain. In the US, there are two different sets of guidelines: One by the American Heart Association and American College of Cardiology (2013), and the other by the USPSTF (United States Preventive Services Task Force). The former's guidelines cover a wider base of who should take statin.

However, the Indian Journal of Endocrine and Metabolism states that "guidelines set abroad do not have a representative South Asian population."

Health experts state that guidelines have been lowered all the time to include more patients under statin care. Dr Maryanne Demasi, an investigative reporter from Sydney, writes in her study that statins were initially recommended for people with existing heart disease (as a secondary prevention option), but manufacturers quickly sought to increase the indications of the drug and next target population was healthy people (as a primary prevention measure).

The study adds that one prominent cardiologist even published an article in the American Journal of Cardiology stating that statins should be offered as condiments at burger outlets.

The idea of this article is not to create panic for those prescribed statins. We just thought we will look at the other side of 'wonder' drug.

WHAT ARE STATINS?

• Statins are a class of lipid-lowering medications, found to reduce cardiovascular disease (CVD) and mortality in those at high risk of CVD. 
   
• They help lower cholesterol levels in the blood, thus preventing heart attacks and stroke.